Duns Number:649185170
Device Description: A plate indicated for fractures, osteotomies, and non-unions of the metaphyseal and diaphy A plate indicated for fractures, osteotomies, and non-unions of the metaphyseal and diaphyseal region of the distal fibula, including in osteopenic bone.
Catalog Number
PDFLN2004S
Brand Name
Piccolo Composite Plate System
Version/Model Number
Distal Fibula Plate
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K120409,K130061
Product Code
HRS
Product Code Name
Plate, Fixation, Bone
Public Device Record Key
096041a9-bef9-479b-b3b1-4a306383a12e
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
February 04, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1387 |